Infusion and sensing device with battery charging and data transferring mechanisms

ABSTRACT

Disclosed is a portable ambulatory fluid delivery device. The device includes a dispensing unit to dispense therapeutic fluid, the dispensing unit including one or more rechargeable batteries, a housing to retain the one or more rechargeable batteries, a reservoir to contain the therapeutic fluid, a driving mechanism to cause delivery of the therapeutic fluid from the reservoir to a user&#39;s body, and at least one electrical connector to be coupled to a recharging unit to direct electrical power received from the recharging unit to recharge the one or more rechargeable batteries. At least a portion of the housing is securable to a skin of the user.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of Ser. No. 12/921,824, filed on Sep.10, 2010 now U.S. Pat. No. 8,641,672, which is a 35 U.S.C. §371 nationalstage entry of PCT/IL2009/000266 having an international filing date ofMar. 10, 2009 and claims the benefit of U.S. Provisional PatentApplication No. 61/035,288, filed in the U.S. Patent & Trademark Officeon Mar. 10, 2008. The present application incorporates herein byreference the contents of each of the above-referenced applications intheir entireties.

FIELD

Embodiments of the present disclosure relate generally to a system, adevice and a method for sustained medical infusion of fluids and/orcontinuous monitoring of body analyte. More particularly, the presentdisclosure is directed to systems, devices and methods that include adevice that comprises a portable dispenser and/or an analyte sensorpowered by rechargeable energy storage cell and mechanisms to rechargethe batteries and transfer data.

BACKGROUND

Diabetes and Insulin Pumps

Medical treatment of several illnesses/conditions requires continuousdrug infusion into various body compartments, for example, throughsubcutaneous and intra-venous injections. Patient suffering fromDiabetes mellitus (DM), for example, require the administration ofvarying amounts of insulin throughout the day to control their bloodglucose levels. In recent years, ambulatory portable insulin infusionpumps have emerged as an alternative to multiple daily syringeinjections of insulin, initially for Type 1 diabetes patients (see, forexample, Diabetes Medicine 2006; 23(2):141-7) and subsequently for Type2 (see, for example, Diabetes Metab 2007 Apr. 30, Diabetes Obes Metab2007 Jun. 26). Such pumps, which deliver insulin at a continuous and/orperiodic basal rates as well as in bolus volumes, were developed toliberate patients from having to perform repeated self-administeredinjections, and to enable them to maintain a near-normal daily routine.Both basal and bolus volumes have to be delivered in substantiallyprecise doses, according to individual prescription, because an overdoseor under-dose of insulin could be fatal.

Insulin Pump Generations

The first generation of portable insulin pumps included “pager like”devices each having a reservoir contained within a housing. A long tubedelivered insulin from the pump attached to a patient's belt to a remoteinsertion site. The reservoir, delivery tube and the hypodermic cannulatogether constituted an “infusion set”. With these first-generationdevices it is recommended that they be replaced every 2-3 days to avoidlocal infection at the cannula insertion site. Such devices aredisclosed, for example, in U.S. Pat. Nos. 3,631,847 3,771,694, 4,657,4864,544,369, the contents of all of which are hereby incorporated byreference in their entireties. These devices represent a significantimprovement over multiple daily injections, but tend to be relativelylarge in size and in weight. Additionally, these devices generallyrequire long tubing, making the device somewhat bulky and cumbersome towear and carry. One reason for the relatively large weight and size ofthese devices is the large sized batteries (e.g., of AA or AAA-type)required for meeting the high energy demand of the motor, screen,alarms, and other power consuming components of the devices.

The bulkiness of first generational insulin pump devices (in partbecause of the long tubing used) harms the devices popularity with manydiabetic insulin users because these devices disturb users' regularactivities, e.g., sports activities, like swimming.

To avoid the tubing limitation, a new concept for a second generationwas proposed. The new concept was based on a remote controlled skinadherable device with a housing having a bottom surface adapted forcontact with the patient's skin, with a reservoir contained within thehousing, and with an injection needle adapted to be in fluidcommunication with the reservoir. These skin securable (e.g., adherable)devices are designed to be replaced every 2-3 days, similarly to thecurrently available pump infusion sets. However, many patients prefer toextend this period until reservoir emptying. The second-generationparadigm is described, for example, in U.S. Pat. Nos. 4,498,843,5,957,895, 6,589,229, 6,740,059, 6,723,072, and 6,485,461, the contentsof all of which are hereby incorporated by reference in theirentireties. Second-generation skin securable devices generally requirethat the entirety of the devices be disposed-of every 3 days, or so,thus resulting in some of the more expensive components (e.g.,electronics, driving mechanism) being discarded. Additionally, a remotecontrolled skin securable device tends to be heavy and bulky, thuscreating an impediment for maintaining daily activity. Here too, onereason for the large size and heavy weight of second generation devicesis their sizes and the relatively large number of batteries they eachhold to supply energy to the devices' motors, alarms, communicationmechanisms used to maintain a communication link between the skinsecurable devices and the remote controls, etc. In U.S. Pat. No.7,144,384, the content of which is hereby incorporated by reference inits entirety, a skin adherable device is disclosed: In one embodiment, alarge portion of the device's volume is occupied by four (4)Silver-Oxide button batteries positioned perpendicularly to thelongitudinal axis of the device, making the device thick (18 mm) andbulky. Moreover, the heavy and bulky batteries used with such insulinpump devices typically last for only 3 days, thus requiring the user todiscarded the expensive device typically every 3 days.

A third generation (3rd gen.) skin adherable device was developed toavoid the price constraints associated with earlier generations and toextend patient customization. An example of such a device is describedin previously filed patent application Ser. No. 11/397,115 and PCTInternational Application No. PCT/IL06/001276, owned by Medingo, thecontents of both these applications is hereby incorporated by referencein their entireties. A third generation device includes a remote controlunit and a skin securable (e.g., adherable) patch unit that includes twoparts:

-   -   A first portion (e.g., a “reusable part”) containing a metering        portion, electronics, and other relatively expensive components.    -   A second portion (e.g., “disposable part”) containing the        reservoir retaining therapeutic fluid (e.g., insulin) and, in        some embodiments, batteries. The disposable part also includes a        tube to deliver the fluid from the reservoir to an outlet port        that contains a connecting lumen.

The third-generation device concept provides a cost-effective skinadherable infusion device and enables diverse usage with differentreservoir sizes, different needle and cannula types, etc.

Continuous Glucose Monitors (CGM) and Closed Loop System

Continuous sensing of bodily analytes within the interstitial fluid ofthe subcutaneous (SC) tissue is described, for example, in U.S. Pat.Nos. 5,390,671, 5,391,250, 5,482,473, 5,299,571, and 6,565,509, thecontents of all of which are hereby incorporated by reference in theirentireties. These sensing devices each includes, in some embodiments, asubcutaneous probe and a sensing unit that contains a processing unitand energy supply. In previously filed U.S. patent application Ser. No.11/706,606, entitled “Systems and methods for sensing analyte anddispensing therapeutic fluid”, the content of which is herebyincorporated by reference in its entirety, an insulin dispenser and aglucose sensor are disclosed that are contained within one skin adheredunit that is provided with a reusable part and a disposable part. Insuch a dual function device, a closed loop system may be implementedwhere insulin is dispenses based on, at least in part, sensed glucoselevels (artificial pancreas). In some embodiments, the batteries residein the reusable part of this dual unit.

Pump and Sensors Batteries Recharging

A first generation infusion pump powered by rechargeable batteries isdescribed in U.S. Pat. No. 5,225,763 to Krohn et al., the content ofwhich is hereby incorporated by reference in its entirety. The batteriescan be recharged by a base unit connected to AC power. Under somecircumstances, the pump operation of such a device might have to besuspended during charging. This may be unacceptable for insulin pumpusers because stopping the delivery of insulin may be detrimental to theusers' health.

Use of rechargeable batteries in second generation skin adherable pumpsis of less importance because the entire device is generally disposed-ofevery few days (insulin pump are usually disposed-of every 2-3 days).Moreover, batteries recharging cannot be done during operation becausethe device is connected to the user's body.

In third generation devices, the skin-securable units, each comprises areusable part and a disposable part. If the battery(ies) resides in thereusable part it can be recharged. A patient may use two reusable partsso that when one reusable part is operating the second one is beingrecharged.

In a continuous glucose monitor (CGM) or in a CGM with insulin dispenserthat includes a reusable part and a disposable part, batteries canreside in the reusable part and be recharged when another reusable partis operating.

Pumps and Sensors Data Downloading

Pump log file, recording and maintaining information regarding insulindelivery, have to periodically be downloaded to a PC to be used, forexample, in delivery programs tailoring.

A first generation insulin pump enables data downloading during pumpoperation is described, for example, in U.S. Pat. No. 5,376,070, thecontent of which is hereby incorporated by reference in its entirety.The pump may be connected to a communication station and data may betransferred from the pump using, for example, optical coupling. Inembodiments of such apparatus, the user is tied, in effect, to thecommunication station to avoid drug delivery interruption.

Data downloading in second generation pumps may be performed wirelesslyto a remote control. In the event of remote control loss or malfunction,the data stored in the pump and stored data in the remote control may belost.

In third generation insulin pumps, having reusable and disposable parts,data transfer from one reusable part can be done while another reusablepart is operating.

SUMMARY

Embodiments according to the present disclosure describe a device thatincludes a skin securable (e.g., adherable) dispensing unit (alsoreferred to as the “patch unit” or “dispensing unit”) and a remotecontrol unit (e.g., a unit not directly connected or integrated to thedispensing unit). The patch unit can include an analyte sensor, andtherapeutic fluid can be dispensed according to sensed analyte levels(closed-loop system). The dispensing unit may include at least onebattery that can be recharged. In some embodiments, the dispensing unitmay include a disposable part and a reusable part. The disposable partmay include a drug reservoir and outlet port and the reusable part mayinclude relatively expensive components, for example, electronics anddriving mechanism(s). In some embodiments, the rechargeable batteriesare contained in the reusable part and may have relatively thindimensions (e.g., less than 5 mm). Examples of suitable batteries havingsuch dimension include batteries manufactured by Excellatron SolidState, LLC, U.S.

In some embodiments, during operation of one reusable part, thebatteries of a second reusable part can be recharged. The patch unit,which may include reusable and disposable parts, contains an insulindispenser and/or glucose sensor. After 2-3 days of usage, the disposablepart is replaced and the recharged reusable part becomes operative andcoupled to another disposable part. A fully charged reusable part mayhave, in some embodiments, enough power stored in its batteries tooperate the dispensing unit for at least three days. During this time,the depleted reusable part (i.e., the reusable part that was previouslyoperating while the now used reusable part was being recharged), withrespect to which the power stored in its batteries is not sufficient toenable typical operation of the dispensing device for three days, isrecharged (i.e., its rechargeable batteries are charged).

According to some embodiments, a device is provided that deliverstherapeutic fluid and is provided with at least one battery and amechanism for recharging the at least one battery and transfer data. Insome embodiments, the recharging and data transfer operations mayoperate substantially concomitantly.

According to some embodiments, a device is provided that deliverstherapeutic fluid and can monitor bodily analytes, and is provided withat least one battery and a recharging mechanism to recharge the at leastone battery and to concomitantly transfer data.

According to some embodiments, a device is provided that is configuredto deliver insulin and includes at least one rechargeable battery and arecharging mechanism to recharge the at least one battery. Such a devicemay also include a data transfer mechanism to concomitantly transferdata.

According to some embodiments, a device is provided that deliversinsulin and can monitor glucose levels and is provided with at least onebattery, a mechanism to recharge the at least one battery and transferdata. Such a device may perform these various functions substantiallyconcomitantly.

According to some embodiments, a device is provided that deliversinsulin and is provided with at least one battery, and a mechanism torecharge the at least one battery that includes an internal powersource. Battery recharging could thus be performed without interruptionwith normal operations and without the need of another power source.

According to some embodiments, a device is provided that deliversinsulin and is provided with at least one battery and a mechanism torecharge the at least one battery. Battery recharging can be donewithout interruption with normal operation.

Further, according to some embodiments, a device is provided thatdelivers insulin and can monitor glucose levels, and includes at leastone battery and one or more mechanisms to recharge the at least onebattery and to concomitantly transfer data. Battery recharging and datatransferring may be done without interruption with normal operation ofthe device.

Additionally, according to some embodiments, a device is provided thatincludes a skin securable (e.g., adherable) dispensing unit thatdelivers insulin and can monitor glucose levels, and includes at leastone battery and a one or more mechanisms to recharge the at least onebattery and to substantially concomitantly transfer data.

According to some embodiments, a device is provided that includes a skinsecurable dispensing unit to deliver insulin and which includes at leastone rechargeable battery and one or more mechanisms to recharge the atleast one battery and to substantially concomitantly transfer data. Thedispensing unit may include a reusable part and a disposable part, andthe at least one battery may be located in the reusable part.

According to some embodiments, a device is provided that includes a skinsecurable dispensing unit to deliver insulin and which can monitorglucose levels, and is provided with at least one battery and one ormore mechanisms to recharge the at least one battery and substantiallyconcomitantly transfer data. The dispensing unit may include a reusablepart and a disposable part and the at least one battery may be locatedin the reusable part.

In some embodiments, a skin securable dispensing unit that includes atleast one battery and one or more mechanisms to recharge the at leastone battery is provided.

In some embodiments, a two-part dispensing patch unit and one or moremechanisms to charge batteries disposed in the reusable part isprovided.

In some embodiments, a recharging unit is provided. The recharging unitcan substantially concomitantly supply power to at least one patch unitand/or at least one reusable part, and to the remote control unit. Therecharging unit can be powered by an AC/DC voltage converter and/or byat least one battery. Recharging can be performed with magneticinduction, i.e., a primary winding in the recharging unit that iselectrically coupled to a secondary winding in the dispensing unit.

In some embodiments, the recharging unit includes a data transfermechanism to and from at least one patch unit and/or the at least onereusable part. Data can be transferred by, for example, magneticinduction, an RF link, etc.

In some embodiments, the dispensing unit or the reusable part contains aUSB connector that includes a power supply and a data transfer mechanismwith any USB host (e.g., a PC).

The term USB host refers to mechanism, device, system, etc., configuredto supply power and transfer data through the same connection, such asHost Controller Device (HCD), TS connectors, TRS connectors, PS/2connectors, Mini-DIN connector, Universal Host Controller Interface(UHCI), USB On The Go, etc.

The term PC (personal computer) refers to an electrical device thatincludes a USB host, including, but not limited to, personal computers,PDAs, cellular phones, USB hubs and the like.

In some embodiments, a portable recharging unit that can control thedispensing unit is disclosed. The recharging unit includes a userinterface (e.g., LCD display and operating buttons) configured toreceive commands from a user and provide information to the user. Theconnection between the recharging unit and the dispensing unit can be awired-connection (e.g., USB) and/or a wireless connection.

In one aspect, a portable ambulatory fluid delivery device is disclosed.The device includes a dispensing unit to dispense therapeutic fluid, thedispensing unit including one or more rechargeable batteries, a housingto retain the one or more rechargeable batteries, a reservoir to containthe therapeutic fluid, a driving mechanism to cause delivery of thetherapeutic fluid from the reservoir to a user's body, and at least oneelectrical connector to be coupled to a recharging unit to directelectrical power received from the recharging unit to recharge the oneor more rechargeable batteries. At least a portion of the housing issecurable to a skin of the user.

Embodiments of the device may include one or more of the followingfeatures.

The device may further include the recharging unit.

The dispensing unit may further include a communication module tocommunicate data signals representative of data relating to operation ofthe dispensing unit, the communication module being configured tocommunicate the data signals substantially concomitantly with receipt ofthe electrical power from the recharging unit.

The at least one electrical connector of the dispensing unit may includea USB connector configured to direct the electrical power and the datasignals.

The communication module may include a wireless transceiver to establisha communication link with an external remote controller communicatingthe data signals.

The at least one electrical connector may include at least onetransducer configured to be electromagnetically coupled to a secondtransducer disposed in the recharging unit. The second transducer may beconfigured to cause inductive transfer of the electrical power from thesecond transducer to the first transducer. The inductively transferredelectrical power may include a power signal modulated based on datarelating to operation of the dispensing unit.

The dispensing unit may further include a communication module todemodulate and determine, based on the modulated power signal, the datarelating to the operation of the dispensing unit.

The at least one electrical connector may include at least one dedicatedrecharging electrical terminal to receive the electrical power from therecharging unit, and at least one dedicated data terminal to performbi-directional communication of data relating to operation of thedispensing unit.

The dispensing unit may include a first portion having at least aportion of the driving mechanism, a communication module, the at leastone electrical connector and the one or more rechargeable batteries, anda second portion having a reservoir containing the therapeutic fluid.The dispensing unit may be operable upon connection of the first portionand the second portion. The at least one electrical connector may beconnectable to the recharging unit when the first portion isdisconnected from the second portion. The first portion may include areusable part of the dispensing unit and the second portion may includea disposable part of the dispensing unit.

The device may further include a cradle unit configured to adhere to theskin of the user. The dispensing unit may be connectable anddisconnectable to and from the cradle unit.

The device may further include a remote control unit configured tocommunicate with the dispensing unit.

The dispensing unit may be configured to perform one or more of, forexample, dispensing the therapeutic fluid to the user and/or sensinganalyte levels of the user while the one or more batteries are chargedby the recharging unit.

In another aspect, a recharging device to recharge a fluid deliverydevice is disclosed. The recharging device includes at least oneelectrical connector configured to couple to at least a part of aportable ambulatory dispensing unit of the fluid delivery device toprovide electrical power to the dispensing unit to recharge one or morerechargeable batteries disposed in the dispensing unit, and a charger todirect the electrical power from a power source to the at least oneelectrical connecter. The charger is further configured to alter theelectrical power directed from the power source.

Embodiments of the recharging device may include one or more of thefeatures described above in relation to the fluid delivery device, aswell as any of the following features.

The device may further include a communication module to communicatedata signals representative of data relating to operation of thedispensing unit.

The at least one electrical connector may be configured to provide theelectrical power substantially concomitantly with communication of thedata signals through the communication module.

The at least one electrical connector may include a first electricalconnector configured to be coupled to the dispensing unit, and at leastone other electrical connector to be coupled to another dispensing unit.

The at least one electrical connector may be configured to couple to atleast a part of a remote control unit of the fluid delivery device.

The communication module may be configured to receive data from thedispensing unit and transmit the received data to another dispensingunit.

The recharging device may further include a storage device to store datarelating to operation of the dispensing unit.

The at least one electrical connector may include at least onetransducer configured to cause inductive transfer of the electricalpower from the at, least one transducer to another transducer disposedin the dispensing unit.

The inductively transferred electrical power may include a power signal.The recharging device may further include a communication module tomodulate the power signal based on data relating to operation of thedispensing unit such that a communication module of the dispensing unitcan determine, based on the inductively transferred modulated powersignal, the data relating to the operation of the dispensing unit.

The recharging device may further include a portable power sourceincluding at least one battery to generate at least a portion of theelectrical power directed to the dispensing unit.

The recharging device may further include a housing containing the atleast one electrical connector. The housing may be configured to besubstantially stationary such that when at least part of the dispensingunit is coupled to the at least one electrical connector, fluid deliveryby the dispensing unit is suspended.

The recharging device may further include a portable housing containingthe at least one electrical connector such that the at least oneelectrical connector in the portable housing is configured to be coupledto the at least the part of the dispensing unit while the dispensingunit is operating.

The at least one electrical connector may be configured to couple to afirst portion of a dispensing unit, the first portion retaining the oneor more rechargeable batteries. The dispensing unit may be operable uponconnection of the first portion and at least another portion. Therecharging device may be configured to operate in accordance with EN-IEC60602 standard.

In a further aspect, a method for recharging a portable ambulatorydispensing unit of a fluid delivery device is disclosed. The methodincludes providing the dispensing unit, the dispensing unit having oneor more rechargeable batteries to store energy to power the dispensingunit and at least one electrical connector, providing a rechargingdevice having at least one electrical connector, coupling at least apart of the dispensing unit to the recharging device so that the atleast one electrical connector of the dispensing unit is in electricalcommunication with the at least one electrical connector of therecharging device, and directing electrical power from the rechargingdevice to the dispensing unit to recharge the one or more rechargeablebatteries.

Embodiments of the method may include one or more of the featuresdescribed above in relation to the fluid delivery device and therecharging device, as well as any of the following features.

The method may further include communicating data signals representingdata relating to operation of the dispensing unit between the dispensingunit and the recharging device.

The method may further include communicating the data signals to anotherdispensing unit coupled to the recharging device.

The method may further include storing data signals representing datarelating to operation of the dispensing unit on a storage device of therecharging device.

Directing the electrical power to the dispensing unit may includeinductively transferring electrical power from a first transducer of therecharging device to a second transducer of the dispensing unit.

Inductively transferring electrical power may include inductivelytransferring a power signal, modulating the power signal based on datarelating to operation of the dispensing unit, and determining, based onthe inductively transferred modulated power signal, the data relating tothe operation of the dispensing unit.

Directing electrical power may include directing electrical power torecharge a first portion of the dispensing unit, the first portionhaving the one or more rechargeable batteries to store energy to powerthe dispensing unit.

The method may further include coupling at least another dispensing unitto the recharging device and communicating data signals between thedispensing unit and the at least other dispensing unit.

The method may further include coupling at least one remote control unitto the recharging device and directing electrical power to the at leastone remote control unit.

In yet another aspect, a therapeutic delivery system is disclosed. Thesystem includes a dispensing unit including a disposable partconnectable to one of two or more reusable parts, each of the two ormore reusable parts having one or more rechargeable batteries to storeenergy to power the dispensing unit and a recharging device configuredto recharge at least one of the two or more reusable parts while anotherof the two or more reusable parts is connected to the disposable part.

Embodiments of the system may include one or more of the featuresdescribed above in relation to the fluid delivery device, the rechargingdevice and the method, as well as any of the following features.

The recharging device may further be configured to charge an externalremote controller configured to generate control signals to control oneor more of operation of the dispensing unit and operation of a glucosesensor to sense analyte levels of a patient, the glucose sensor beingcoupled to the therapeutic delivery system.

The recharging device may include a communication module to communicatedata signals with at least one of, for example, the dispensing unit, apersonal computer and/or an external remote controller configured togenerate control signals to control operation of the dispensing unit.

The recharging device may be configured to recharge the at least one ofthe two or more reusable parts by one of, for example, an inductivecoupling element and/or an electrical conduction element.

In another aspect, a therapeutic fluid delivery system is discloses. Thesystem includes a recharging device to recharge a dispensing unit havinga disposable part connectable to one of two or more reusable parts, eachof the two or more reusable parts having one or more rechargeablebatteries to store energy to power the dispensing unit, the rechargingdevice including at least one electrical connector to direct electricalpower to recharge at least one of the two or more reusable parts whileanother of the two or more reusable parts is connected to the disposablepart.

Embodiments of the fluid delivery system may include one or more of thefeatures described above in relation to the fluid delivery device, therecharging device, the method and the first-described system, as well asany of the following features.

The at least one electrical connector may include at least one inductivecoupling element, the at least one inductive coupling element configuredto cause inductive transfer of electrical power from the at least oneinductive coupling element to corresponding inductive coupling elementsdisposed in each of the two or more reusable parts.

The at least one electrical connector of the recharging device mayinclude at least one electrical terminal to mechanically andelectrically couple with corresponding complementary at least oneelectrical terminal in each of the two or more reusable parts.

The at least one electrical connector of the recharging device mayinclude at least one dedicated recharging electrical terminal to directoutput power, and at least one dedicated data terminal to communicatedata signals representative of the data relating to operation of thedispensing unit.

The details of one or more variations of the subject matter describedherein are set forth in the accompanying drawings and the descriptionbelow. Other features and advantages of the subject matter describedherein will be apparent from the description and drawings, and from theclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 a-e are schematic diagrams of exemplary single-part dispensingunit and a two-part dispensing unit, with and without operationalbuttons and a remote control unit.

FIGS. 2 a-c are schematic diagrams and views of a single-part dispensingunit and a two-part dispensing unit (2 b) employing a peristalticpumping mechanism.

FIGS. 3 a-b are schematic diagrams of exemplary single-part dispensingunit and a two-part dispensing unit employing a syringe-piston pumpingmechanism.

FIG. 4 are block diagrams depicting an exemplary energy supply from arecharging unit to a dispensing unit's electrical components.

FIG. 5 a is a perspective view of an exemplary recharging unitconnectable to a rechargeable reusable part.

FIG. 5 b is a perspective view of an exemplary two-part rechargeabledispensing unit.

FIG. 5 c is a perspective view of an exemplary recharging unit withAC/DC transformer connectable to a rechargeable reusable part of adispensing unit.

FIG. 6 is a schematic diagram of an exemplary magnetic induction energytransfer mechanism from a recharging unit to a rechargeable dispensingunit.

FIG. 7 a is a perspective view of an exemplary inductively rechargingunit connectable to a rechargeable dispensing unit.

FIGS. 7 b-c are perspective views of an exemplary recharging unitconnectable to an exemplary rechargeable reusable part of a dispensingunit.

FIG. 8 is a schematic diagram of an exemplary rechargeable dispensingunit with an RF recharging mechanism.

FIG. 9 is a perspective view of an exemplary portable recharging unitconnectable to a rechargeable dispensing unit.

FIG. 10 is a block diagram of an exemplary energy and data transferimplementation between a recharging unit and a dispensing unit with aremote control.

FIGS. 11 a-b are perspective views of exemplary rechargeable dispensingunits with USB plugs.

FIG. 12 is a perspective view of a rechargeable reusable part with a USBplug and a recharging unit with a USB socket.

FIGS. 13 a-b are schematic diagrams of exemplary energy and datatransfer implementations between a recharging unit and a dispensingunit.

FIGS. 14 a-e are views and diagrams depicting exemplary replacementoperations of a depleted reusable part of a dispensing unit with arecharged reusable part.

FIGS. 15 a-b are diagrams depicting an exemplary recharging andsynchronizing unit connectable to two reusable parts, a remote controland a PC.

FIGS. 16 a-b are views of an exemplary dispensing unit and a portablerecharging and controlling unit.

FIG. 17 is a diagram depicting an exemplary interior configuration of aportable recharging and controlling unit.

FIGS. 18 a-b are diagrams showing exemplary data transferimplementations between a portable recharging and controlling unit, a PCand a dispensing unit.

DETAILED DESCRIPTION

Disclosed are systems, devices and methods for recharging a rechargeabledispensing unit that dispenses therapeutic fluid. In some embodiments, aportable ambulatory fluid delivery device is disclosed. The deviceincludes a dispensing unit to dispense therapeutic fluid, the dispensingunit including one or more rechargeable batteries, a housing to retainthe one or more rechargeable batteries, a reservoir to contain thetherapeutic fluid, a driving mechanism to cause delivery of thetherapeutic fluid from the reservoir to a user's body, and at least oneelectrical connector to be coupled to a recharging unit to directelectrical power received from the recharging unit to recharge the oneor more rechargeable batteries. At least a portion of the housing issecurable to a skin of the user. Recharging the one or batteries maythus be performed with the batteries disposed in the dispensing unit(i.e., it is not necessary to remove the batteries from the dispensingunit to have them recharged.) In some embodiments, the one or morebatteries are recharged while the portable device continues to operate,thus avoiding any interruptions in the delivery of therapeutic fluid(e.g., insulin) to the patient. The dispensing unit may include acommunication module to communicate data signals representative of datarelating to operation of the dispensing unit substantially concomitantlywith receipt of electrical power from the recharging unit. For example,in some implementations, power transfer may be implemented throughinductive transfer of electrical power in which a power signaltransferred between the recharging unit and the fluid delivery device ismodulated based on the data relating to operation of the dispensingunit.

In some embodiments, a recharging device to recharge a fluid deliverydevice includes at least one electrical connector configured to coupleto at least a part of a dispensing unit of the fluid delivery device toprovide electrical power to the dispensing unit to recharge one or morerechargeable batteries disposed in the dispensing unit. In someembodiments, the recharging device is configured to direct electricalpower to recharge at least one of two or more reusable parts whileanother of the two or more reusable parts is connected to the disposablepart.

Referring to FIG. 1 a, a schematic diagram of a fluid delivery devicethat includes a dispensing unit 10 and a remote control unit 40 isshown. In some embodiments, the dispensing unit 10 may be a single partunit (as depicted in FIG. 1 b) or a two-part unit (as depicted in FIG. 1c). In embodiments in which a two-part unit is used, the dispensing unit10 includes a first portion (e.g., a reusable part) 100 and a secondportion (e.g., a disposable part) 200. The dispensing unit 10 may beimplemented using different dispensing mechanisms, such as asyringe-type reservoir with a propelling plunger, peristaltic positivedisplacement pumps, etc. In some embodiments, the dispensing unit 10 canbe secured (e.g., adhered) to a patient's body. In some embodiments, thepatch unit includes a dispensing apparatus for delivering therapeuticfluids (e.g., insulin) and a sensing apparatus for sensing analytes(e.g., glucose) within the body.

Infusion programming, data transferring and control of the dispensingunit can be performed using a remote control unit 40 which may beimplemented as a PDA (Personal Digital Assistant), watch, cellular phoneor the like, and/or by using operational buttons 151 disposed on thedispensing unit 10. The remote control unit 40 is configured toestablish a unidirectional or bidirectional communication link with thedispensing unit 10. As shown in FIG. 1 d, in some embodiments, thedispensing unit 10 includes a display 150 and operational buttons 151for controlling and programming the dispensing unit 10. In someembodiments, the two-part dispensing unit 10 (such as, for example, thetwo-part unit shown in FIG. 1 e), includes a reusable part 100 anddisposable part 200. The reusable part 100 of such embodiments includesa user interface (e.g., a display 150 and operational buttons 151). Theconfigurations of the dispensing units shown in FIGS. 1 a-e are alsodescribed, for example, in previously filed U.S. ProvisionalApplications Nos. 60/963,148 and 61/004,019, the contents of which arehereby incorporated by reference in their entireties.

FIGS. 2 a, 2 b and 2 c are schematic diagrams and views of an exemplarydispensing unit 10 employing a peristaltic pumping mechanism fordispensing therapeutic fluid to a user's body.

Referring to FIG. 2 a, a schematic diagram of a single-part dispensingunit 10 is shown. The fluid is delivered from a reservoir 220 to anoutlet port 210 through peristaltic squeezing of a tube 230 by a rotarywheel 110. A description of an exemplary positive displacement pump thatmay be used in conjunction with the dispensing unit 10 of FIG. 2 a isprovided, for example, in previously filed U.S. patent application Ser.No. 11/397,115, the content of which is hereby incorporated by referencein its entirety. A driving mechanism 120, including gears and a motor,e.g. a Stepper motor, DC motor, SMA actuator and the like, can be usedfor rotating the rotary wheel 110. The driving mechanism 120 iscontrolled by a controller module (e.g., a module including electroniccomponents, such as CPU) residing in the dispensing unit 10. Suchelectronic components may include, in some embodiments, aprocessor-based device and a transceiver (transmitter/receiver unit).The electronic components of the controller module are schematicallydesignated by a reference numeral 130. A rechargeable energy storageunit (e.g., one or more batteries, including one or more rechargeablebatteries) 240 and electrical coupling connectors (also refer-to as“connectors” or electrical connectors) 171 (e.g., a DC socket) thatenable electrical connection to an outer power source (such astransformer connected to a home power or a plug to a car DC socket) arealso provided. The connectors are connected to a charging mechanism(which may include a rectifier and/or a voltage stabilizer to transferthe power required for charging the rechargeable energy storage unit 240without overheating or overcharging it).

Infusion programming may be performed through the remote control unit(not shown in FIG. 2 a) and/or by operating buttons 151 disposed on thedispensing unit 10.

Referring to FIG. 2 b, a schematic diagram of a two-part dispensing unit10 that includes a reusable part 100 and a disposable part 200 is shown.The reusable part 100 includes a positive displacement pump providedwith a rotary wheel 110, a driving mechanism 120, electronic components130 (implementing, for example, an electronic controller to control thepump) and a rechargeable energy storage unit 240. The disposable part200 includes a reservoir 220, a delivery tube 230 and an outlet port210. Further details regarding an arrangement such as this are provided,for example, in previously filed U.S. patent application Ser. No.11/397,115, the content of which is hereby incorporated by reference inits entirety. Dispensing of therapeutic fluid is achieved when thedispensing unit 10 is assembled by mechanically connecting the reusablepart 100 and disposable part 200. An, indicator indicating that the twoparts are in proper connection is provided by a socket 132, located inthe reusable part 100, and a plug 270, located in the disposable part200. When the dispensing unit 10 is properly assembled the plug 270 andthe socket 132 are connected so as to establish a closed electricalcircuit that causes the indicator to be powered and thus to indicate theconnection status of the two parts. In some embodiments, the socket 132may also function as a connector to an external power source.Consequently, the rechargeable battery/batteries (of the energy storageunit 240) can be recharged when the dispensing unit is disassembled tothus enable the establishing an electrical connection between the energystorage unit 240 and an electrical outlet. In these embodiments, thereare no exposed connectors when the dispensing unit 10 is assembled, thuspreventing the occurrences of short circuits. Alternatively, in someembodiments the socket is located in the reusable part and the plug islocated in the disposable part.

FIG. 2 c is an isometric view of an exemplary two-part dispensing unit10. As shown, the reusable part 100 and the disposable part 200 areconnected, thus constituting the dispensing unit 10 in its assembledstate. Fluid delivery programming can be performed using a remotecontrol unit (not shown) or by operational buttons 151 located on thereusable part 100 housing.

FIGS. 3 a and 3 b are schematic diagrams of exemplary embodiments of adispensing unit 10 employing a piston/plunger pumping mechanism. Adescription of embodiments of a dispensing unit employing this type ofpumping mechanism is disclosed, for example, in previously filed U.S.provisional application No. 60/928,751, filed on the May 11, 2007, thecontent of which is hereby incorporated by reference in its entirety.

Referring to FIG. 3 a, as shown, in some embodiments, the dispensingunit 10 is a two-part dispensing unit having a reusable part 100 and adisposable part 200.

-   -   The disposable part 200 includes: a reservoir 220 coupled to a        plunger 110 and an outlet port 210. In some embodiments, the        plunger 110 may be located in the reusable part 100 or may        extend over both parts such that a section of the plunger 110 is        located in the reusable part 100 and another section of the        plunger 110 is located in the disposable part 200. As further        shown, a plug 270 is also provided to indicate whether the        disposable part 200 is connected to the reusable part 100 such        that when the reusable part 100 and the disposable part 200 are        mechanically secured to each other an indication circuit other        an indication circuit connected to a socket 132 located in the        reusable part 100 is electrically closed thus causing the        indication circuit to be activated    -   The reusable part 100 includes: a driving mechanism 120, which        includes a motor (e.g., Stepper motor, DC motor, SMA actuator        and the like), and gears to displace the plunger 110. The        driving mechanism 120 is controlled by electronic controls 130        which may include a controller, processor and transceiver (not        shown). Infusion programming can be carried out by a remote        control unit (not shown) and/or by one or more operating buttons        151 disposed at the exterior surface of the dispensing unit 10.        At least one rechargeable battery 240 disposed in the reusable        part 100 provides energy to at least some of the        modules/components of the reusable part 100 such as the motor.        The charging current to recharge the rechargeable battery 240 is        delivered via connectors 171. Recharging operations may be        controlled by the dispensing unit electronic controls 130.

Referring to FIG. 3 b, a single-part dispensing unit 10 is shown thatincludes a • reservoir 220 coupled to a plunger 110 and an outlet port210. The dispensing unit 10 further includes a driving mechanism 120,which includes a motor (e.g., Stepper motor, DC motor, SMA actuator orthe like), and gears to displace the plunger 110. The driving mechanism120 is controlled by electronic controls 130 which may include acontroller, processor and transceiver (not shown). Infusion programmingcan be carried out by, a remote control unit (not shown) and/or by oneor more operating buttons 151 disposed at the exterior portion of thedispensing unit 10. At least one rechargeable battery 240 disposed inthe reusable part 100 provides energy to at least some of themodules/components of the reusable part 100 such as the motor. Thecharging current to recharge the rechargeable battery 240 is deliveredfrom a charging unit via connectors 171. Recharging operations may becontrolled by the dispensing unit electronic controls 130.

Referring to FIG. 4, schematic block diagrams of an exemplary rechargingunit 30 and an exemplary dispensing unit 10 are shown. The rechargingunit 30 includes a charger 305 that directs charging current 17 to thedispensing unit recharging module 170 when the electrical couplingconnectors 171 and 306 of the dispensing unit 10 and the recharging unit30, respectively, are coupled to each other. The set of electricalconnections 306 (e.g., DC connector, USB plug, coil, etc.) is generallyincluded in the recharging unit 30 while the other set of electricalconnections 171 is included in the dispensing unit 10. The dispensingunit recharging module 170 directs charging current to the rechargeableenergy storage (e.g., battery) 240. Thus, the battery 240 can be chargedwhile embedded in the dispensing unit 10 (i.e., the energy storage 240may be an internal battery that does not have to be removed from thehousing of the dispensing unit 10). The battery 240 supplies energy tocomponents of the dispensing unit 10 such as the driving mechanism,processor, transceiver, etc. The charging current 17 may be transferredto the dispensing unit 10 wirelessly, e.g. by induction, RFtransmission, etc., or it may be transferred to the dispensing unit bywires.

The recharging unit 30 can include an internal power source 300 (e.g.,solar cell, one or more batteries, etc.), and/or can be connected to anexternal power source such as a power line, a car DC socket, or to otherdevice power outlets such as a USB host.

In some embodiments, the electrical communication between the dispensingunit 10 and the recharging unit 30 (e.g., when the recharging unit 30 isdirecting charging energy to the dispensing unit) may be detected bymeasurement of voltage or current at the electrical connectors 171and/or 306 of the dispensing unit 10 or recharging unit 30,respectively. In such embodiments, additional components may berequired, e.g., a processor and/or digital logical circuitry for use,for example, with an analog to digital (A/D) converter.

Referring to FIG. 5 a, a perspective view of an exemplary rechargeablereusable part 100 connectable to a recharging unit 30 to charge therechargeable reusable part is shown. The recharging unit 30 includesconnectors 306, power cords 381 and plug 380 to connect the rechargingunit 30 to an external power source. The connectors 306 are mechanicallyconnectable to the reusable part electrical connectors 171 to provideelectrical connection between the recharging unit 30 and the reusablepart 100. Plug 380 enables delivery of power current to the rechargingunit 30 from a household power wiring.

FIG. 5 b is a perspective view of an exemplary two-part dispensing unitthat includes a rechargeable reusable part 100 and a disposable part200. Housings 101 and 201 of the reusable part 100 and the disposablepart 200, respectively, form, in some embodiments, a water tight sealusing elastic seals 221 a and 221 b. Mechanical coupling of the rotarywheel 110 and the tube 230 enables peristaltic pumping. A vent 202,covered by a selectively permeable membrane (e.g. Gore-Tex®) 203, isprovided to, for example, balance the pressures between the interior andthe exterior of the disposable part 200. A description of an exemplarywater tight dispensing pump is provided, for example, in previouslyfiled Provisional Application No. 60/961,382, entitled “VentedDispensing Device and Method,” the content of which is herebyincorporated by reference in its entirety. While FIG. 5 b shows anembodiment of a dispensing unit implemented with a peristaltic pumpingmechanism, in some embodiments, the dispensing unit may include othertypes of pumping mechanisms, including, for example, mechanisms withsyringe-based reservoirs and propelling plungers, etc. Furthermore, insome embodiments, the vent, such as the vent 202 of FIG. 5 b, may belocated in other parts of the dispensing unit, including, for example,the reusable part of the dispensing unit. In some embodiments, both thereusable and disposable parts of a dispensing unit may include vents tofacilitate the dispensation functionality of the unit. Electricalconnectors 171 protrude from the sealed housing 101 to enable electricalconnection to the recharging unit's connectors. A socket 272 is providedin the disposable part housing 201 that is connectable to the connectors171 of the reusable part 100 when the two parts of the dispensing unit10 are attached. The socket 272 may include (or be coupled to) anindication mechanism to indicate when the two parts (i.e., the reusablepart 100 and the disposable part 200) are attached.

Referring to FIG. 5 c, a perspective view of an exemplary rechargeablereusable part 100 connectable to a charger 30 that includes a plug 380,a charger 305 (e.g., AC/DC transformer), power cords 381 and a connector306 (e.g., a DC plug) is shown. The reusable part 100 of the dispensingunit comprises a connector 171 (e.g., DC socket) connectable to theconnector 306 (DC plug) to recharge the rechargeable energy storage(battery) 240.

Referring to FIG. 6, a schematic diagram of an exemplary rechargeabledispensing unit 10 coupled to a recharging unit 30 having a magneticallyinductive energy transfer mechanism is shown. The recharging unit 30includes a primary winding 3061, an AC converter 3051 (functionallyequivalent, for example, to the charger 305 shown in FIG. 4), powercords 381 and a plug 380. The recess 31 located in the recharging unit30 is configured to be spatially aligned with the dispensing unit 10such that when the dispensing unit 10 is received within the recess 31the two windings 3061 and 1711 are spatially positioned as a two-parttransformer. Energy (e.g., current) supplied through the plug 380 isconverted by the AC converter 3051 to a required AC voltage/currentlevel power (in terms of frequency, amplitude, etc.) and transferred byprimary winding 3061 to the secondary winding 1711. Descriptions ofseparable transformers are provided, for example, in U.S. Pat. Nos.3,418,552, 3,840,795, 3,939,391, 4,374,354, 4,942,352, 5,157,319 and5,680,028, the contents of all of which are hereby incorporated byreference in their entireties. The charger 1701 may include a rectifier,which converts the AC voltage/current received by the secondary winding1711 to a DC power level (i.e., DC voltage/current levels) required tocharge the battery 240. In some embodiments, the charger 1701 alsoregulates the charging of the battery 240 to prevent overheating orovercharging. A description of such charger regulating functionality isprovided, for example, in U.S. Pat. No. 4,065,712, the content of whichis hereby incorporated by reference in its entirety. In someembodiments, the charging process is performed in accordance with therequirements (e.g., safety, compatibility, insulation) of such standardsas the standards for medical devices EN-IEC 60601 or EN-IEC 60602.

With continued reference to FIG. 6, the primary and secondary windings3061 and 1701 constitute the electrical connection in a manner similar,for example, to the connection constituted by the connectors 306 and 171shown in FIG. 4. The AC converter and DC charger shown in FIG. 6 arefunctionally analogous to the charger 305 and the recharging module 170,respectively, shown in FIG. 4.

Referring to FIG. 7 a, a perspective view of an exemplary rechargingunit 30 to transfer power to a dispensing unit 10 via an inductiveenergy transfer implementation is shown. The recharging unit 30 includesa recharging recess 31 configured to receive the dispensing unit 10 (asingle part dispensing unit or an assembled two-part dispensing unit).The recharging unit 30 further includes a USB plug 3801 and a USB cable3811 to connect it to a USB host (e.g., a personal computer). The USBhost supplies power to the recharging unit 30 when connected. Rechargestatus indication devices, such as, for example, LEDs 340 a and monitor340 b, are provided to indicate the connection and recharging status. Insome embodiments, the status indication device 340 a includes two LEDsthat respectively indicate the connection status between the rechargingunit 30 and the reusable part 100 (denoted as “link”) and the status forthe USB host connection (denoted as “power”). In some embodiments, theindication device 340 b includes a status bar to indicate the chargingprogress. The dispensing unit 10 also includes operating buttons 151 toenable receipt of user inputs, and a display 150 to provide indicationsand outputs.

Referring to FIG. 7 b, a perspective view of another exemplaryrecharging unit 30 configured to house a reusable part 100 of adispensing unit when detached from a disposable part is shown. Two pairsof electrical connectors, namely, one pair of connectors 306 located onthe recharging unit 30 and another pair of connectors located on thebottom side of the reusable part 100 (designated as numeral 171, asshown in FIG. 7 c) provide an electrical connection between the reusablepart 100 and the recharging unit 30 when the reusable part 100 is placedin the recharging recess 31 of the recharging unit 30.

Referring to FIG. 8, a schematic diagram of an exemplary rechargeabledispensing unit 10 that includes a wireless recharging circuit 1702,such as commercially available Powercast™ recharging circuit, and anantenna 1712, is shown. RF waves 17 are received by the antenna 1712 andare converted to DC power by the wireless recharging circuit 1702. Theconverted power is used to charge a rechargeable battery 240. In thisembodiment, the wireless recharging circuit 1702 and antenna 1712 arefunctionally analogous to the recharging module 170 and electricalcoupling connectors 171 shown in FIG. 4.

Referring to FIG. 9, a perspective view of an exemplary portablerecharging unit 30 is shown. The portable recharging unit 30 includes:

-   -   An internal power source 300 (e.g., two batteries), thus        avoiding the need for charging from stationary power source        (e.g., home power socket), and enabling the dispensing unit 10        to be recharged while being carried.    -   A USB connector 3066 connectable to a USB port 1716 located in        the dispensing unit 10 (in a two-part dispensing unit, the USB        port 1716 may be located on the reusable part of the unit). When        electrically coupled, the recharging unit power source 300        supplies the energy to the dispensing unit 10 and thus the        dispensing unit can be recharged without movement or traveling        limitations.

In some embodiments, the dispensing unit 10 can be recharged by theportable recharging unit 30 during operation, thus avoiding treatmentinterruption.

Referring to FIG. 10, a block diagram of a system that enables energyand data transfer between a dispensing unit 10 in communication with aremote control unit 40 and a recharging unit 30 is shown. The rechargingunit includes a processor 320, a communication module 310 and datastorage module 330. A communication link 16 established between thedispensing unit 10 and the recharging unit 30 enables, for example, thebackup of data stored in the dispensing unit 10, and further enablesupdating of data stored in the dispensing unit (e.g., user related data,including infusion profiles, software or firmware updates, etc.). Datastored in the data storage module 330 of the recharging unit 30 isprocessed by the processor 320 and transferred through the rechargingunit's communication module 310 to the dispensing unit's communicationmodule 160, and vice versa. The dispensing unit 10 also includes an RFtransceiver 260 to communicate, e.g., through an established RFcommunications link 261, with the remote control unit 40. In someembodiments, communications links 16 and/or 261 other than the RFcommunication links may be used. For example magnetic links, infrared(IR) communication links, wired communication links, etc., may be usedin addition to or instead of RF links. The communications links 16and/or 261 may be unidirectional or bi-directional.

Referring to FIG. 11 a, a perspective view of an exemplary system thatincludes a reusable part 100 with a USB plug 1714 to transfer data andenergy is shown. When the reusable part 100 is coupled to a disposablepart 200 to form an assembled dispensing unit, the USB plug 1714 ismechanically connected to a USB socket 2704. An indication device (notshown) may provide an indication as to whether the USB socket 2704 andplug 1714 are mechanically connected. The reusable part 100 isconnectable, e.g., via a USB plug to a USB host (not shown in thefigure). When connected to the USB host, energy and/or data can betransferred between the reusable part and the USB host. The data sotransferred may have been, or may subsequently be, stored, edited and/ormanaged.

Referring to FIG. 11 b, a perspective view of another exemplary systemthat includes a reusable part 100 with a mini-USB jack 1715 (instead ofstandard USB plug “A” type) is shown. The mini-USB plug 1715 is smallerthan the standard USB plug “A”, and thus can be applied more discreetlyin a dispensing unit 10 (i.e., the mini-USB jack is less conspicuousthan the USB plug “A” shown in FIG. 11 a). In some embodiments, thereusable part 100 can further include a display/screen 150 andoperational buttons 151.

Referring to FIG. 12, a perspective view of an exemplary systemincluding a recharging unit 30 that can be recharged through a car'slighter plug is shown. The recharging unit 30 of FIG. 12 includes a USBsocket 3054 connectable to the reusable part's USB plug 1714, a carlighter plug 3802 that may include a DC/DC converter for converting thevoltage provided from a car lighter plug (usually 6 v or 12 v) to thevoltage required to operate the dispensing pump (e.g., 5 v) or to bestored in an energy storage cell (e.g., one or more rechargeablebatteries) disposed in the reusable unit 10. The recharging unit 30 alsoincludes a power cord 381, a USB cable 3811 and a USB plug 3801 tocommunicate with a USB host (not shown). The car lighter plug 3802 canprovide power to the dispensing unit 10 when a USB connection to a USBhost is not available. In some embodiments, the recharging unit 30 canbe connected simultaneously to a USB host and to another power source.

Referring to FIGS. 13 a and 13 b, block diagrams of exemplary systemsincluding a recharging and data transferring unit 30 based onmagnetically inductive coupling implementations are shown. Containedwithin each of the recharging unit 30 and a dispensing unit 10 coupledthereto are transceivers 3101 and 1601, respectively, which cansimultaneously transmit and receive inductive communications signals.Full duplex operation may be implemented by echo cancellation,transmission and reception at different frequencies, time divisionduplex and the like. Alternatively and/or additionally, in someembodiments, separate transmitting and receiving transducers may beused.

In some embodiments, the recharging unit 30 and the dispensing unit 10may communicate through frequency modulation of inductive fields,although other modulation methods such as amplitude or phase modulationmay be employed. While charging, the distance between the rechargingunit 30 and the dispensing unit 10 is, in some embodiments, less than 2cm. This short distance reduces inductive field's radiation and noisesgenerated by other electrical signals. As a result, use of aninterference rejection circuitry may be limited or altogether notnecessary.

The recharging unit transducer (primary winding) 3061 includes a coil ora ferric rod and coil wrapped around it. In some embodiments, a recess31 defined in the recharging unit 30 is configured to hold and align thedispensing unit 10 so as to place the dispensing unit transducer 1711 ina pre-defined established position (e.g., perpendicular, parallel andthe like) relative to the recharging unit transducer 3061. Thepre-defined established relative alignment of the transducers 1711 and3061 simplifies the operation and control of the recharging and the datatransfer processes because electromagnetic induction efficiency andother consequential effects (e.g., dot conversion, mutual induction,etc.) can be achieved from the relative alignment of the transducers1711 and 3061.

The transducers 1711 and 3061 are connected to transceivers 1601 and3101, respectively, which are controlled by electronics modules 130 and301, respectively. The recharging unit electronics module 301 typicallyincludes a processor, data storage device(s), and an indication device(none are shown in FIGS. 13 a-b). In some embodiments, the transducerscan direct the power from the recharging unit to another device (e.g.the dispensing unit, the remote control) and/or communicate the databetween the recharging unit and another device.

Referring to FIG. 13 b, a block diagram of another exemplary system inwhich the energy and data are transferred from a recharging unit 30 to adispensing unit 10 using one transmission signal is shown. The batterycharger signal generator 305 is configured to generate a carrier wavethat provides the energy signal (e.g., a high power current). Thecarrier signal is modulated such that a higher frequency data signal issuperimposed on the carrier signal using the transceiver 3101. Thedispensing unit 10 includes high and low pass filters 162 and 172,respectively, that selectively enable data and power to reach thetransceiver 1601 and DC charger 1701, respectively.

In some embodiments, other techniques, such as zero-crossing techniques,pulse modulation, phase modulation, amplitude modulation or frequencymodulation, may be used to transfer data and/or energy between therecharging unit 30 and the dispensing unit 10.

In some embodiments, at least one coil is included in one or more units(e.g., the dispensing unit 10, the recharging unit 30 and a remotecontrol unit 40) to provide wireless magnetic communication over longerdistances (e.g., 30 cm and longer), as described, for example, in U.S.Pat. Nos. 5,771,438, 5,912,925, 5,982,764, 6,459,882, 7,142,811 and7,254,366, the contents of all of which are hereby incorporated byreference in their entireties.

Referring to FIGS. 14 a to 14 e, views and diagrams depicting anexemplary procedure to enable replacement of a depleted reusable part100 b with a charged reusable part 100 a is illustrated.

In particular, FIG. 14 a shows a dispensing unit 10 b detachablyconnected to the user via a cradle unit 20. A cradle unit such as theone shown in FIG. 14 a is also described in co-owned/co-pending U.S.Ser. No. 12/004,837, filed on the Dec. 20, 2007, the content of which ishereby incorporated by reference in its entirety.

FIG. 14 b shows a disposable part 200 b and a reusable part 100 b. Thereusable part 100 b includes two connectors: a power connector 171 and adata connector 1615. When the reusable part and the disposable part areset apart, the connectors 171 and 1615 are exposed and the reusable part100 b can thus be connected to the recharging unit 30, as shown in FIG.14 c.

FIG. 14 c shows a recharging unit 30 that includes two sets ofconnectors (denoted as a and b), each of which includes a data plug(3105 a and 3105 b, respectively) and a power plug (3055 a and 3055 b,respectively), enabling simultaneously charging of two differentreusable parts (100 a and 100 b, respectively). As shown in FIG. 14 c, acharged reusable part 100 a is already connected to recharging unit 30at the time that a depleted reusable part 100 b is about to beconnected. Also detachably connected to the recharging unit 30 via a USBplug 3801 is a personal computer (PC) 50 (e.g., an iMac™ commerciallyavailable by Apple Inc., USA), which provides power to the rechargingunit 30, and also provides data processing and storage functionalitiesto enable data management of the dispensing units connected to therecharging unit 30. An indication device, e.g., a display 340 (e.g.,LCD) provides information and indications regarding the status of theconnections, power transfer, data transfer and the like. Suchinformation may also be displayed on the PC 50. In some embodiments, thePC 50 may be a laptop, iPod, cellular phone or any other wire/wirelesselectronic device which includes memory and/or processor.

FIG. 14 d shows the two separate reusable parts 100 a and 100 bmechanically (and electrically) connected simultaneously to therecharging unit 30. The connection between the two reusable parts 100 aand 100 b can be used to transfer data between them. For example, flowdelivery programs update (e.g., basal and bolus profiles, etc.) can betransferred from the depleted reusable part 100 b to the rechargedreusable part 100 a, thus preserving data and delivery profiles used bythe user, and enabling the user to avoid having to re-program thecharged reusable part 100 a.

FIG. 14 e shows the final stage of reusable part 100 a replacement. Thedepleted part 100 b is recharged by the recharging unit 30 and thecharged and updated reusable part 100 a is disconnected from therecharging unit 30. The charged and updated reusable part 100 a may thenbe connected to a disposable part, and the assembled dispensing unit canbe attached, for example, to the cradle 20 (shown in FIG. 14 a).

Referring to FIGS. 15 a-b, diagrams depicting an exemplary rechargingunit 30 connectable to a remote control unit 40 and to a pair ofreusable parts 100 a and 100 b are shown. The remote control unit 40 (amagnified view of which is shown in FIG. 15 b) includes electricalconnectors 42 to enable electrical connection to the recharging unit 30set of connectors 3955. Connecting the remote control unit 40 to therecharging unit 30 enables charging the remote control unit 40 and/orproviding a two-way communication with all the connected units, namely,the reusable parts 100 a and 100 b, the recharging unit 30 and aUSB/remote host 50.

Referring to FIGS. 16 a and 16 b, views of an exemplary portablerecharging unit 30 that can also control the dispensing unit 10 areshown. The recharging unit 30 includes an indication device 340 (e.g.,an LCD) and a user input interface 311 (e.g., a keypad and/or operatingbuttons/switches). The recharging unit also includes data and energytransfer mechanism implemented, for example, using a USB plug 3066connectable to a dispensing unit 10. The dispensing unit 10 does notrequire an indication device or user input interface (because those mayalready be provided through the recharging unit 30) and thereforemanufacture of the dispensing unit may be performed in a more costefficient manner. Alternatively, in some embodiments, the dispensingunit connectable to the recharging unit 30, as shown in FIG. 16 a, mayalso have a separate indication device 150 and a separate user inputinterface 151 disposed on the housing of the dispensing unit 10 (asshown in FIG. 16 b). The user inputs received by the user inputinterface 311 of the recharging unit are transferred to the dispensingunit 10. Communication between the dispensing unit 10 and the rechargingunit 30 is established upon plugging the USB plug 3066 to the USB socket1716 directly or through an extension cord 370 (as shown in FIG. 16 b).In some embodiments, wireless communication between the portablerecharging unit 30 and the dispensing unit 10 may be implemented byincluding wireless communication modules (e.g., RF transceivers) in bothunits.

Referring to FIG. 17, a diagram of an exemplary portable rechargeableunit is shown. The portable rechargeable unit includes:

-   -   A USB plug 3066 connected to a communication module 310, e.g. a        USB interface that enables sending and receiving data and        energy.    -   A processor 320 to control the operation of the rechargeable        unit.    -   A charger 305 for recharging the internal rechargeable energy        storage cell 300. The charger 305 charges the internal energy        storage cell 300 (which may include one or more rechargeable        batteries) when connected to a voltage of, for example, 5 v or        higher (as provided by standard USB host). In some embodiments,        when the charger 305 is connected to a voltage source outputting        a voltage level below some pre-determined threshold, e.g., 3 v        or lower, it supplies power from energy storage cell 300 to the        dispensing unit. Alternatively, in some embodiments, the        portable rechargeable unit can include one or more replaceable        power sources, such as button size batteries or AAA batteries.

The recharging unit 30 may also includes a data storage module 330 tostore software, user information, fluid delivery profiles such as basalprofiles (amounts of drug to be delivered in specified time periods),etc. A User input interface 311, an indication device 340 and an RFtransceiver 1646 with an antenna 1636 to enable wireless communicationmay also be provided.

FIG. 18 a is a diagram showing a recharging unit 30 connected to USBsocket 51 of a personal computer (PC) 50, for recharging its internalenergy storage cell and/or for data transfer.

FIG. 18 b is a diagram showing an RF communication link 261 establishedbetween a recharging unit 30, a personal computer (PC) 50 and adispensing unit 10. The dispensing unit 10 is connectable to therecharging unit 30 and/or to the PC 50 and can also receive commands viathe RF communication link 261 and/or operating buttons 151.

Although a few variations have been described in detail above, othermodifications are possible. For example, the logic flow depicted in theaccompanying figures and described herein does not require theparticular order shown, or sequential order, to achieve desirableresults. Other implementations may be within the scope of the followingclaims.

What is claimed is:
 1. A therapeutic fluid delivery system comprising: adispensing unit comprising: a housing; one or more rechargeablebatteries in the housing; a reservoir for holding a therapeutic fluid; adriving mechanism for delivering the therapeutic fluid from thereservoir to a user's body; at least one first electrical connectorelectrically connected to the one or more rechargeable batteries; and atleast one first communication module; and a charging unit configured todirect an electrical power from a power source to the dispensing unit,the charging unit comprising: at least one second electrical connectorcoupleable to the at least one first electrical connector of thedispensing unit to provide electrical power to charge the one or morerechargeable batteries when the charging unit is connected to thedispensing unit; and at least one second communication module configuredto communicate with the at least one first communication module of thedispensing unit including communicating one or more data signalsrepresentative of data relating to one or more operations of thedispensing unit when the dispensing unit receives electrical power fromthe charging unit.
 2. The system according to claim 1, wherein the atleast one first electrical connector of the dispensing unit includes aUSB connector configured to direct the electrical power and the datasignals; and wherein the at least one first communication module of thedispensing unit is coupled to the USB connector.
 3. The system accordingto claim 1, wherein the at least one first communication module of thedispensing unit includes a wireless transceiver to establish acommunication link with an external remote controller.
 4. The systemaccording to claim 1, wherein the at least one first electricalconnector of the dispensing unit includes at least one dedicatedcharging electrical terminal to receive the electrical power from thecharging unit; and at least one dedicated data terminal to performbi-directional communication of data relating to operation of thedispensing unit.
 5. The system according to claim 1, further comprisinga cradle unit configured to adhere to the skin of the user, thedispensing unit being connectable to and disconnectable from the cradleunit.
 6. The system according to claim 1, wherein the dispensing unit isconfigured to perform one or more of dispensing the therapeutic fluid tothe user and sensing analyte levels of the user while the one or morebatteries are charged by the charging unit.
 7. The system according toclaim 1, wherein the at least one second communication module of thecharging unit is configured to communicate data signals with at leastone of: the dispensing unit, a personal computer, and an external remotecontroller configured to generate control signals to control operationof the dispensing unit.
 8. The system according to claim 1, wherein thedispensing unit further comprises a disposable part connectable to oneof two or more reusable parts, each of the two or more reusable partshaving one or more rechargeable batteries to store energy to power thedispensing unit, and wherein the at least one second electricalconnector of the recharging unit is configured to direct electricalpower to recharge at least one of the two or more reusable parts whileanother of the two or more reusable parts is connected to the disposablepart.
 9. The system according to claim 8, wherein the at least onesecond electrical connector of the recharging device is coupleable tothe at least one of the two or more reusable parts when the at least oneof the two or more reusable parts is disconnected from the disposablepart.
 10. The system according to claim 8, wherein the at least onefirst electrical connector of the dispensing unit is configured to beaccessed by the charging unit when the at least one of the two or morereusable parts is disconnected from the disposable part.
 11. The systemaccording to claim 8, further comprising one or more elastic sealsconfigured and arranged to form a watertight seal between the disposablepart and one of the two or more reusable parts upon connection of thedisposable part and the one of the two or more reusable parts.
 12. Thesystem according to claim 1, wherein the at least one secondcommunication module is further configured to communicate with a furtherdispensing unit coupleable to the charging unit.
 13. The systemaccording to claim 1, wherein the housing of the dispensing unitcomprises a portion securable to a skin of the user.
 14. The systemaccording to claim 1, wherein the one or more data signals arecommunicated substantially concomitantly upon receipt of the electricalpower by the dispensing unit from the charging unit.
 15. The systemaccording to claim 1, wherein the at least one first electricalconnector includes at least one first transducer and the at least onesecond electrical connector includes a second transducer configured tobe electromagnetically coupled to the first transducer, the secondtransducer being further configured to cause inductive transfer of theelectrical power from the second transducer to the first transducer. 16.The system according to claim 15, wherein the inductively transferredelectrical power includes a power signal modulated based on datarelating to operation of the dispensing unit.